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Closed Versus Open Cells Stent for Acute Myocardial Infarction (COCHISE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alessandro Sciahbasi, Policlinico Casilino ASL RMB
ClinicalTrials.gov Identifier:
NCT01152138
First received: June 25, 2010
Last updated: May 16, 2012
Last verified: May 2012
History of Changes
  Purpose

The aim of this study is to determine whether a closed cell stent design may reduce distal embolization and no reflow during primary percutaneous coronary intervention (PPCI) for acute ST-elevation acute myocardial infarction (STEMI) compared to an open cell stent design. The study population will include all consecutive patients admitted for acute STEMI and treated with PPCI within 12 hours from symptom onset.


Condition Intervention
Acute Myocardial Infarction
Primary Percutaneous Coronary Intervention
 Device: Open cells stent
Device: Closed Cells Stent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: COCHISE Pilot Study: Closed vs Open Cells Stent for High Risk Percutaneous Coronary Interventions in ST Elevation Acute Myocardial Infarction

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by Policlinico Casilino ASL RMB:

Primary Outcome Measures:
  • Post procedural angiographic evaluation [ Time Frame: whithin 1 day ] [ Designated as safety issue: No ]
    The corrected Thrombolysis In Myocardial Infarction (TIMI) frame count at the end of the procedure defined as the number of frames required to opacify angiographic landmarks and normalized for vessel length and a composite end-point including angiographic events such as distal embolization, slow-flow (decrease in flow from TIMI 3 to TIMI 2) or no-reflow (decrease from TIMI 2 or 3 to TIMI 0 or 1) and a binary electrocardiographic criterion of microvascular injury as defined by the presence of persistent (>50% of initial value) ST-segment elevation 30-60 min after procedure


Secondary Outcome Measures:
  • Post stent angiographic results and in hospital MACE [ Time Frame: whithin 7 days ] [ Designated as safety issue: No ]
    The corrected Thrombolysis In Myocardial Infarction (TIMI) frame count after stent deployment; a composite angiographic end-point including angiographic events such as distal embolization, slow-flow (decrease in flow from TIMI 3 to TIMI 2) or no-reflow (decrease in flow from TIMI 2 or 3 to TIMI 0 or 1) after stent deployment; the infarct size detect by myocardial enzyme release, in hospital major adverse cardac events (MACE)(death, reinfarction, target lesion revascularization)


Enrollment: 223
Study Start Date: March 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Open Cell Stent
Open cell stent (Driver™ or Integrity™,Medtronic), routinely employed during percutaneous coronary interventions for ST elevation acute myocardial infarction
 Device: Open cells stent
Cobalt Chromium Stent with open cell design
Other Names:
  • Driver Stent, Medtronic
  • Integrity Stent, Medtronic
Active Comparator: Closed Cell Stent
Closed cell stent (Presillion Plus™, Cordis), routinely employed during percutaneous coronary interventions for ST elevation acute myocardial infarction
 Device: Closed Cells Stent
Cobalt Chromium stent with closed cell design
Other Name: Presillion Plus Stent, Cordis

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with an age > 18 years with acute ST elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PPCI) within 12 hours from symptom onset and who agree and provide written informed consent. STEMI is defined as chest pain associated with ST-elevation of 1 mm or more in two or more contiguous leads or new left bundle-branch block within 12 hours after the onset of chest pain

Exclusion Criteria:

  • implanted stent with diameter < 2.5 mm
  • cardiogenic shock
  • time from pain onset to PPCI >12 hours
  • previous thrombolytic therapy (rescue PPCI)
  • inability to provide informed consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01152138

Locations
Italy
UOC Cardiologia - Policlinico Casilino - ASL RMB
Rome, Italy
UOC Cardiologia - Ospedale Belcolle
Viterbo, Italy
Sponsors and Collaborators
Alessandro Sciahbasi
Investigators
Principal Investigator: Alessandro Sciahbasi, MD Policilnico Casilino - ASL RMB
  More Information

No publications provided

Responsible Party: Alessandro Sciahbasi, Medical doctor, Policlinico Casilino ASL RMB
ClinicalTrials.gov Identifier: NCT01152138     History of Changes
Other Study ID Numbers: COCHISE
Study First Received: June 25, 2010
Last Updated: May 16, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Policlinico Casilino ASL RMB:
Acute myocardial infarction
Closed cell stent
Open cell stent
primary percutaneous coronary intervention

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013